FDA Grants Priority Review To Insmed's sNDA For Arikayce For Treatment Of Mac Lung Disease With PDUFA Target Action Date Set For January 28, 2027 - INSM News | Rallies
FDA grants priority review for Arikayce supplemental filing
Insmed Incorporated said the FDA granted priority review to its supplemental new drug application (sNDA) for Arikayce® (amikacin liposome inhalation suspension) for treatment of MAC lung disease.
The company said the PDUFA target action date is set for January 28, 2027.
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